Week in Review: FDA approves RSV vaccine | Non-respiratory revenues rise | Latent TB screening

Leo Photo

Dear LabPulse.com reader:

The rise of influenza, respiratory syncytial virus (RSV), and COVID-19, often referred to as the tripledemic, has motivated the development of multiplex tests to detect and differentiate each condition. Treatments and vaccines that can be deployed after a diagnosis generally make tests more valuable. While there are vaccines for COVID-19 and influenza, they have not been available for RSV. However, the U.S. Food and Drug Administration (FDA) this week approved the use of GlaxoSmithKline Biologicals’ Arexvy vaccine for RSV.

QuidelOrtho on Wednesday reported first-quarter revenue of $846.1 million, a drop of 15% from $1 billion in Q1 2022 and in line with preliminary revenue estimates announced in April. On a supplemental combined basis, as if Quidel and Ortho had been combined for the applicable periods, first-quarter respiratory testing revenue, including COVID-19 test sales, fell 72% year-over year. On the other hand, non-respiratory testing revenue rose 5% from Q1 2022.

Qiagen this week reported first-quarter net sales of $485 million, a decline of 23% from $628 million in Q1 2022. CEO Thierry Bernard described the quarter on a conference call to discuss the financial results. “Net sales at [constant exchange rates] for the first quarter were $502 million and exceeded our outlook for at least $490 million," he said. "On the other hand, due to Q1 2022 being an exceptionally strong quarter for COVID testing, we had sizable headwinds as expected in COVID product sales in the first quarter of 2023.”

A statement from the U.S. Preventive Services Task Force (USPSTF) may benefit Qiagen and other makers of tests for latent TB. USPSTF reaffirmed that it recommends screening for latent tuberculosis infection in populations at increased risk. Its document, published Tuesday in JAMA Network, was based on a systematic review to update 2016 recommendations. Qiagen said in a statement that it welcomed the recommendations. It and PerkinElmer’s Oxford Immunotech, the leading providers of interferon-γ release assays for latent TB testing, are expected to benefit.

Meanwhile, UC San Francisco academic medical center is set to become the first among California hospitals to offer pharmacogenetic testing that helps pharmacists tailor medications and dosages to each patient’s genetic makeup. When patients agree to undergo pharmacogenetic testing, UC San Francisco will bill their insurance and provide results within two weeks.

Unaffected by Brexit, the U.K. IVD market reached $4.6 billion in 2022, according to an estimate by Kalorama Information, a sister brand of LabPulse, in its 30-Country IVD Market Atlas. Point-of-care testing will drive most growth in the market, especially tests related to glucose, coagulation, critical care, fecal occult blood (FOB), and ID/AST.


Thank you for reading.

Leo O’Connor

Editor in Chief

Page 1 of 179
Next Page